Systemic sclerosis & Raynaud's
Safety and effectiveness of tocilizumab in systemic sclerosis: a multicentre French-Italian study
Authors' conclusion
In this large real-life cohort, TCZ was safe and associated with consistent benefits across different domains, supporting its role as a potential disease-modifying treatment in selected patients with SSc.
Study context
- Population
- Patients with systemic sclerosis (SSc) treated with tocilizumab (TCZ), French-Italian multicentre cohort (88% female; median age 57 years; median disease duration 9 years; 67% antitopoisomerase I positive)
- Participants
- 197 patients15 referral centres
- Outcome
- Real-life safety and effectiveness of TCZ on several SSc-related domains (mRSS, pulmonary function tests, DAS28-CRP, digital ulcers, cardiac biomarkers)
- Follow-up
- 12 and 24 months
Methodological detailsmulticentre, 15 referral centres, real-life
- Multicentre
- 15 referral centres
- Real-life
Main finding
As reported in the abstract
%pFVC and interstitial lung disease (ILD) progressors in SSc-associated ILD (progression: decline ≥5 in %pFVC over 12±3 months)
%pFVC declined from −12 months to baseline (before TCZ)
81% to 77%
p=0.003
On TCZ introduction, %pFVC stabilised; proportion of progressors declined
43% to 24%
p=0.015
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| TCZ discontinuation | TCZ 32% |
TCZ discontinuation
- Mainly for inefficacy
Predictors of response
- PAH and older age predicted TCZ failure; elevated CRP predicted better response
Safety
Infections (the most frequent AEs)
- Infections, most frequent AEs
- 22.8%
TCZ discontinuation
- Discontinued TCZ, mainly for inefficacy
- 32%
Original publication
Safety and effectiveness of tocilizumab in systemic sclerosis: a multicentre French-Italian study. RMD Open. Published 9 June 2026. doi:10.
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